Pantoprazole Sulfone N-Oxide (CAS 953787-55-8) | también denominado 6-(Difluorometoxi)-2-[[(3 | 4-dimetoxi-1-oxido-2-piridinil)metil]sulfonil]-1H-benzimidazol | es una impureza relacionada del principio activo pantoprazol generada por oxidación y reacciones relacionadas con el azufre durante síntesis o almacenamiento. Presenta retos analíticos por su masa y polaridad; su detección y cuantificación se realizan típicamente por HPLC con detección UV y confirmación por LC-MS. Su perfil de impurezas afecta especificaciones y estabilidad del API | por lo que se controlan límites | condiciones de purificación y pruebas de degradación forzada para garantizar cumplimiento regulatorio y calidad del producto final.
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